A Phase 3 interventional study of Azithromycin plus chloroquine and sulfadoxine-pyrimethamine in Intermittent Preventive Treatment In Pregnancy (IPTp), sponsored by Pfizer. Terminated at 9 sites in 5 countries. Open to female participants aged 16 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-16.
Sponsored by Pfizer · Phase 3, Interventional, and Prevention
The primary objective is to establish superiority of AZCQ over SP in protective efficacy for IPTp as measured by the proportion of subjects with sub-optimal pregnancy outcome.
After interim analysis of efficacy data by an External Data Monitoring Committee, this study was terminated. Investigators were notified on 22 Aug 2013. There were no safety concerns that led to this termination.
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Azithromycin/chloroquine
Drug: Azithromycin plus chloroquine
sulfadoxine-pyrimethamine (Fansidar)
Drug: sulfadoxine-pyrimethamine
Drug pages: Azithromycin · Chloroquine
combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
Also known as: Fansidar
Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (\<2,500 g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (\<2,500g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Time frame: Approximately 40 weeks of gestational age
Percentage of Neonates With LBW (<2500 g) in ITT Population
LBW was defined as live birth weight \<2500 g (up to and including 2499 g).
Time frame: Approximately 40 weeks of gestational age
Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population
LBW was defined as live birth weight \<2500 g (up to and including 2499 g).
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation
Severe maternal anemia was defined as Hb \<8 g/dL.
Time frame: At 36-38 weeks of gestation.
Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation
Anemia was defined as Hb \<11 g/dL.
Time frame: At 36-38 weeks of gestation.
Percentage of Participants With Placental Parasitemia at Delivery
Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Placental Malaria at Delivery Based on Histology
Participants positive for placental malaria at delivery were evaluated based on placental histology.
Time frame: Approximately 40 weeks of gestational age
Sexually Transmitted Infection (STI) Episodes Per Participant
Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).
Time frame: Approximately 40 weeks of gestational age .
Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation
Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight \<2,500g), premature birth (\<37 weeks), abortion (≤28 weeks), still birth (\>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
Time frame: Approximately 40 weeks of gestational age.
Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration.
Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.
Time frame: Baseline, at 36-38 weeks of gestation.
Percentage of Neonates With Congenital Abnormalities at Birth
Neonates with congenital abnormalities at birth were noted.
Time frame: Approximately 40 weeks of gestational age.
Percentage of Perinatal or Neonatal Deaths
Percentage of perinatal or neonatal deaths were noted.
Time frame: Day 28 after delivery.
Birth Weight of Live Borne Neonate
Birth weight of live borne neonates were calculated in grams.
Time frame: Approximately 40 weeks of gestational age.
Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery
This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever \>37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery
This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Peripheral Parasitemia at Delivery
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Cord Blood Parasitemia at Delivery
This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation
Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.
Time frame: Upto 36-38 weeks of gestation
Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation
Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation
Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation
Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation
Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.
Time frame: At 36-38 weeks of gestation
Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation.
Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.
Time frame: At 36-38 weeks of gestation
Percentage of Neonates With Ophthalmia Neonatorum at Birth Period
Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.
Time frame: Approximately 40 weeks of gestational age
Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery
Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.
Time frame: Up to approximately 40 weeks of gestational age
Percentage of Participants With Pre-eclampsia From Week 20 to Delivery
Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.
Time frame: From Week 20 to approximately 40 weeks of gestational age
Nasopharyngeal Swabs Positive for Macrolide Resistant Streptococcus Pneumoniae
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.
Time frame: Visits 6 and 7
Nasopharyngeal Swabs Positive for Penicillin Resistant Streptococcus Pneumoniae
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.
Time frame: Visits 6 and 7
This Phase 3, open label, randomized, parallel group study screened a total of 3259 participants in 6 sites. A total of 2891 were treated either with azithromycin+chloroquine or sulfadoxine+pyrimethamine.
| Milestone | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Started | 1446 | 1445 |
| Completed | 969 | 1024 |
| Not completed | 477 | 421 |
| Withdrew: Adverse event | 3 | 1 |
| Withdrew: Lost to follow-up | 68 | 51 |
| Withdrew: Withdrawal by subject | 60 | 15 |
| Withdrew: Other | 16 | 11 |
| Withdrew: Protocol violation | 1 | 0 |
| Withdrew: Study terminated by sponsor | 326 | 342 |
| Withdrew: Death | 3 | 1 |
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with low birth weight (LBW) (\<2,500 g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage Participants With Sub-optimal Pregnancy Outcome in Intent-to-Treat (IIT) Population | 26.16 (23.89 to 28.43) | 23.67 (21.48 to 25.86) |
Adverse pregnancy outcomes were defined as live-borne neonate (singleton) with LBW (\<2,500g), premature births (\<37 weeks as confirmed by the Ballard score), abortion (≤28 weeks), still birth (\>28 weeks), lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
| Percentage of Participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Sub-optimal Pregnancy Outcome in Efficacy Analyzable Per Protocol (PP) Population | 10.38 (8.57 to 12.19) | 10.12 (8.40 to 11.84) |
LBW was defined as live birth weight \<2500 g (up to and including 2499 g).
| Percentage of neonates | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Neonates With LBW (<2500 g) in ITT Population | 5.01 (3.74 to 6.28) | 5.72 (4.40 to 7.04) |
LBW was defined as live birth weight \<2500 g (up to and including 2499 g).
| Percentage of neonates | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Neonates With LBW (<2500 g) in Efficacy Analyzable PP Population | 4.72 (3.43 to 6.01) | 5.21 (3.92 to 6.50) |
Severe maternal anemia was defined as Hb \<8 g/dL.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Severe Maternal Anemia (Hemoglobin [Hb] <8 g/dL) at 36-38 Weeks of Gestation | 1.80 (1.05 to 2.55) | 2.00 (1.24 to 2.76) |
Anemia was defined as Hb \<11 g/dL.
| Percentage of Participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Maternal Anemia (Hb <11 g/dL) at 36-38 Weeks of Gestation | 50.57 (47.77 to 53.37) | 49.11 (46.39 to 51.83) |
Participants with placental parasitemia at delivery were diagnosed using Placental blood smear at birth from participants who deliver at hospital.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Placental Parasitemia at Delivery | 5.30 (3.92 to 6.67) | 5.67 (4.29 to 7.05) |
Participants positive for placental malaria at delivery were evaluated based on placental histology.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Placental Malaria at Delivery Based on Histology | 4.81 (3.51 to 6.11) | 5.73 (4.36 to 7.10) |
Number of episodes of sexually transmitted infection episodes per participant were noted. The STI's including Treponema pallidum, Neisseria gonorrhoeae, Chlamydia trachomatis, from first dose to delivery (diagnosis was based on clinical presentation and lab results).
| Number of episodes | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Sexually Transmitted Infection (STI) Episodes Per Participant | 0.14 (0.11 to 0.16) | 0.19 (0.17 to 0.21) |
Sub-optimal pregnancy outcome including neonatal deaths and congenital malformations, defined as any of the following: live-borne neonate (singleton) with low birth-weight (or LBW for short, defined as live birth weight \<2,500g), premature birth (\<37 weeks), abortion (≤28 weeks), still birth (\>28 weeks), neonatal death, congenital malformation, lost to follow-up prior to termination of pregnancy or delivery, or missing birth weight of the neonates.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Sub-optimal Pregnancy Outcome Including Neonatal Death and Congenital Malformation | 28.51 (26.18 to 30.84) | 26.51 (24.23 to 28.79) |
Change from Baseline to 36-38 weeks of gestation in Hb concentration was noted.
| g/dL | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Change From Baseline to 36-38 Weeks of Gestation in Hb Concentration. | 0.13 (0.05 to 0.21) | 0.27 (0.19 to 0.34) |
Neonates with congenital abnormalities at birth were noted.
| Percentage of neonates | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Neonates With Congenital Abnormalities at Birth | 2.19 (1.34 to 3.04) | 2.44 (1.56 to 3.31) |
Percentage of perinatal or neonatal deaths were noted.
| Percentage of neonates | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Perinatal or Neonatal Deaths | 2.19 (1.34 to 3.04) | 1.85 (1.08 to 2.62) |
Birth weight of live borne neonates were calculated in grams.
| grams | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Birth Weight of Live Borne Neonate | 3148.3 (3120 to 3176) | 3146.2 (3119 to 3174) |
This outcome measure determined if an episode of malaria started within the time period of first dose to delivery. Clinical episode of malaria was determined if the participant presented with clinical symptoms of malaria (fever \>37.5°C, oral) and diagnosed (either by rapid diagnostic tests or microscopy) with malaria.
| Number of episodes | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Number of Episodes of Symptomatic Malaria Per Participant From First Intermittent Preventive Treatment of Falciparum Dose to Delivery | 0.06 (0.04 to 0.08) | 0.13 (0.11 to 0.15) |
This outcome measure evaluated the participants requiring additional treatments for malaria during the study period following the first dose (diagnosed based on clinical presentation and/or lab test results).
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants Requiring Additional Treatment for Symptomatic Malaria From First Dose to Delivery | 5.74 (4.54 to 6.94) | 10.52 (8.94 to 12.10) |
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at 36-38 weeks of gestation. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Peripheral Parasitemia at 36-38 Weeks of Gestation | 2.71 (1.74 to 3.68) | 4.38 (3.19 to 5.57) |
This outcome measure evaluated the percentage of participants positive for peripheral parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Peripheral Parasitemia at Delivery | 6.05 (4.59 to 7.51) | 7.46 (5.90 to 9.02) |
This outcome measure evaluated the percentage of participants positive for cord blood parasitemia at delivery. A participant was positive for parasitemia if the number of asexual parasites per μL was \>0.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Cord Blood Parasitemia at Delivery | 0.49 (0.06 to 0.92) | 0.75 (0.23 to 1.27) |
Sexual transmitted disease included Treponema pallidum, Neisseria gonorrhoeae, and Chlamydia trachomatis infections. This was diagnosed based on clinical presentation prior to Week 36-38 and/or lab test results between Week 36-38.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Sexually Transmitted Infections From First Dose to 36-38 Weeks of Gestation | 12.32 (10.63 to 14.01) | 16.47 (14.56 to 18.38) |
Participants positive for Chlamydia trachomatis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Chlamydia Trachomatis Infection at 36-38 Weeks of Gestation | 1.47 (0.61 to 2.33) | 0.63 (0.08 to 1.18) |
Participants positive for Neisseria gonorrhoeae infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected and PCR assay was used for analysis.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Neisseria Gonorrhoeae Infection at 36-38 Weeks of Gestation | 0.40 (0.00 to 0.85) | 1.64 (0.76 to 2.52) |
Participants positive for Treponema pallidum infection was diagnosed based on laboratory result at 36-38 weeks of gestation. Treponema Pallidum particle Agglutination Assay was used.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Treponema Pallidum Infection at 36-38 Weeks of Gestation | 0.93 (0.24 to 1.62) | 2.01 (1.04 to 2.98) |
Participants positive for Trichomonas vaginalis infection was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the laboratory test.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Trichomonas Vaginalis Infection at 36-38 Weeks of Gestation | 8.24 (6.59 to 9.89) | 10.67 (8.88 to 12.46) |
Bacterial vaginosis was diagnosed based on laboratory result at 36-38 weeks of gestation. A vaginal swab was collected for the Gram staining.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Bacterial Vaginosis Infection at 36-38 Weeks of Gestation. | 8.58 (6.57 to 10.59) | 11.84 (9.59 to 14.09) |
Ophthalmia neonatorum was diagnosed at birth. The laboratory diagnosis was performed among neonates with purulent discharge.
| Percentage of neonates | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Neonates With Ophthalmia Neonatorum at Birth Period | 0.35 (0.01 to 0.69) | 0.17 (0.00 to 0.40) |
Participants positive for bacterial infections including other lower respiratory tract infections were measured anytime from first dose administration to delivery.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Bacterial Infections Including Pneumonia and Other Lower Respiratory Tract Infections From First Dose to Delivery | 0.48 (0.13 to 0.84) | 1.25 (0.67 to 1.82) |
Pre-eclampsia was diagnosed as systolic blood pressure of at least 140 mmHg and/or diastolic blood pressure of at least 90 mmHg on two separate readings taken at least 4 hours apart and proteinuria at least 300 mg protein in a 24 hour urine collection.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Percentage of Participants With Pre-eclampsia From Week 20 to Delivery | 0.63 (0.22 to 1.03) | 1.04 (0.51 to 1.55) |
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against macrolide antibiotics.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Visit 6 (N = 8 and 17 respectively) | 0 | 11.76 |
| Visit 7 (N = 16 and 11 respectively) | 0 | 0 |
This outcome measure evaluated the Streptococcus pneumoniae sensitivity against penicillin antibiotics.
| Percentage of participants | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine |
|---|---|---|
| Visit 6 (N = 8 and 17 respectively) | 0 | 0 |
| Visit 7 (N = 16 and 11 respectively) | 0 | 0 |
Collected over Up to Visit 7 (6 months post last dose). Includes data up to 35 days after last dose of study drug for mothers (treatment emergent), and includes all data for neonates.. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mother (Azithromycin + Chloroquine) | — | 65/1,446 (4.5%) | 1,177/1,446 (81.4%) |
| Mother (Sulfadoxine + Pyrimethamine) | — | 42/1,445 (2.9%) | 888/1,445 (61.5%) |
| Neonate (Azithromycin + Chloroquine) | — | 101/1,149 (8.8%) | 301/1,149 (26.2%) |
| Neonate (Sulfadoxine + Pyrimethamine) | — | 104/1,196 (8.7%) | 326/1,196 (27.3%) |
| Event | Mother (Azithromycin + Chloroquine) | Mother (Sulfadoxine + Pyrimethamine) | Neonate (Azithromycin + Chloroquine) | Neonate (Sulfadoxine + Pyrimethamine) |
|---|---|---|---|---|
| PolydactylyCongenital, familial and genetic disorders | 0/1446 | 0/1445 | 16/1149 | 21/1196 |
| Premature babyPregnancy, puerperium and perinatal conditions | 0/1446 | 0/1445 | 17/1149 | 12/1196 |
| Sepsis neonatalInfections and infestations | 0/1446 | 0/1445 | 11/1149 | 13/1196 |
| PneumoniaInfections and infestations | 1/1446 | 1/1445 | 9/1149 | 10/1196 |
| Low birth weight babyPregnancy, puerperium and perinatal conditions | 0/1446 | 0/1445 | 9/1149 | 10/1196 |
| Neonatal asphyxiaRespiratory, thoracic and mediastinal disorders | 0/1446 | 0/1445 | 6/1149 | 9/1196 |
| MalariaInfections and infestations | 2/1446 | 9/1445 | 2/1149 | 3/1196 |
| StillbirthPregnancy, puerperium and perinatal conditions | 5/1446 | 7/1445 | 0/1149 | 0/1196 |
| Haemorrhage in pregnancyPregnancy, puerperium and perinatal conditions | 7/1446 | 1/1445 | 0/1149 | 0/1196 |
| Premature deliveryPregnancy, puerperium and perinatal conditions | 7/1446 | 5/1445 | 0/1149 | 0/1196 |
| Event | Mother (Azithromycin + Chloroquine) | Mother (Sulfadoxine + Pyrimethamine) | Neonate (Azithromycin + Chloroquine) | Neonate (Sulfadoxine + Pyrimethamine) |
|---|---|---|---|---|
| VomitingGastrointestinal disorders | 650/1446 | 96/1445 | 0/1149 | 0/1196 |
| DizzinessNervous system disorders | 460/1446 | 84/1445 | 0/1149 | 0/1196 |
| HeadacheNervous system disorders | 300/1446 | 219/1445 | 0/1149 | 0/1196 |
| AstheniaGeneral disorders | 239/1446 | 40/1445 | 0/1149 | 0/1196 |
| NauseaGastrointestinal disorders | 216/1446 | 58/1445 | 0/1149 | 0/1196 |
| AnaemiaBlood and lymphatic system disorders | 205/1446 | 192/1445 | 21/1149 | 14/1196 |
| DiarrhoeaGastrointestinal disorders | 205/1446 | 14/1445 | 0/1149 | 0/1196 |
| White blood cells urine positiveInvestigations | 149/1446 | 162/1445 | 0/1149 | 0/1196 |
| Upper respiratory tract infectionInfections and infestations | 127/1446 | 153/1445 | 125/1149 | 116/1196 |
| Vision blurredEye disorders | 145/1446 | 1/1445 | 0/1149 | 0/1196 |
| Age, Continuous(Years) | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine | Total |
|---|---|---|---|
| Mean | 23.3 ± 4.5 | 23.3 ± 4.6 | 23.3 ± 4.6 |
| Sex: Female, Male(Participants) | Azithromycin + Chloroquine | Sulfadoxine + Pyrimethamine | Total |
|---|---|---|---|
| Female | 1446 | 1445 | 2891 |
| Male | 0 | 0 | 0 |
The record gives a start of Oct 2010, a primary completion of Oct 2013 and a completion of Nov 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Sep 2014, 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Azithromycin · Chloroquine